Quaternary AmmoniumAQTIFFNCT05247567
Quaternary Ammonium and Immunization in Hairdressers
A study testing serum punction and skin swab in elbow folds in people with Quaternary Ammonium and Hypersensitivity, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
"Quaternary ammonium ions (QA) are surfactants and microbicide products found in a large number of household products, disinfectants and cosmetics. Professional exposure to QA causes allergic diseases of the skin and lung (asthma). It is also the firs cause of occupational rhinitis since 2000. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Quaternary Ammonium, Hypersensitivity
- What is being tested?
- serum punction and skin swab in elbow folds
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteFrance
- Study dates
- 27 Oct 2022to 27 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Being at least 16
- Being regularly registered in a Hairdressing school in first and second year
- Mastery of French language
Who cannot join
- No French speaking parents for underage students
- People under legal guardianship
- French special Health Insurance for non-residents (AME)"
Trial locations and contacts
1 site in 1 country.
About this study
"Quaternary ammonium ions (QA) are surfactants and microbicide products found in a large number of household products, disinfectants and cosmetics.
Professional exposure to QA causes allergic diseases of the skin and lung (asthma). It is also the firs cause of occupational rhinitis since 2000.
Read more
Several studies have found a link between exposure to some disinfectants and asthma in specific population. Moreover, a study showed that exposure to QA found in hairdressing products could also be a risk factor to allergy to neuro-muscular blocking agents.
However, the prevalence of QA sensitization amongst hairdressers is not known, sensitization mechanisms have been poorly characterized. To date, there is no recommendation regarding QA exposure nor classification of QA by toxicity. Finally, the link between hairdressing QA and drug allergy have not been confirmed yet.
The investigator hypothesize that it is possible to sensitize to QA by exposure to hairdressing products and then to declare allergic diseases. The investigator plan to study this hypothesis in an observational prospective cohort of hairdressing students by measuring both sensitization markers in blood and QA exposure. "
Read the detailed description
Quaternary ammonium ions (QA) are surfactants and microbicide products found in a large number of household products, disinfectants and cosmetics.
Professional exposure to QA causes allergic diseases of the skin and lung (asthma). It is also the first cause of occupational rhinitis since 2000.
Several studies have found a link between exposure to some disinfectants and asthma in specific population. The responsibility of the QA in asthma can be demonstrated by in vivo testing (inhalation challenge). Some QA have been shown to directly activate the immune system, in particular didecyldimethylammonium chloride, a common disinfectant, that was demonstrated to act as a sensitizer.
Neuromuscular blocking agents (NMBA) are drugs used during surgery to relax muscles. They all have QA moieties and can trigger sometimes severe IgE-mediated allergic reaction (anaphylaxis). The epitope of these drugs recognized by the Immunoglobulin E (IgE) antibodies are precisely the QA moieties. However, the origin of these IgE is unknown as a significant proportion of patients have anaphylaxis on the first exposure an NMBA. A study showed that exposure to QA found in hairdressing products was linked to anti-IgE QA and then might also be a risk factor to allergy to NMBA.
Thus, QA exposure is strongly suspected to be linked to allergic diseases. However, the prevalence of QA sensitization amongst hairdressers is not known, sensitization mechanisms have been poorly characterized. To date, there is no recommendation regarding QA exposure nor classification of QA by toxicity. Finally, the link between hairdressing QA and drug allergy have not been confirmed yet.
We hypothesize that it is possible to sensitize to QA by exposure to hairdressing products and then to declare allergic diseases. We plan to study this hypothesis in an observational prospective cohort of hairdressing students by measuring both sensitization markers in blood and QA exposure.
The investigator will study 2 groups of hairdressing students :
- first year students, before the beginning of their apprenticeship in a Salon
- third year students Both groups will be programmed for a visit in the Center for Clinical Investigation of the Bichat Hospital, Paris, France. During this visit, after obtention of written consent, a blood sample (10 mL) will be collected in a serum collection tube, and a form about exposure to QA will be filled by the student.
For first year students only, a similar visit will be planned at the end of their studies (2 years after inclusion) Serum will be collected and frozen in a biobank in Bichat Hospital. Total and QA specific IgE and Immunoglobulin G (IgG) will be measured.
Differences in prevalence will be assessed by Fischer's exact test, the link between exposure levels and IgG and IgE levels will be assessed by Spearman correlation, and the evolution of IgE and IgG concentrations over time will be measured by a paired hypothesis test chosen according to data's distribution."
- Conditions
- Quaternary Ammonium, Hypersensitivity
- Being tested
- serum punction, skin swab in elbow folds
- Keywords
- hypersensitivity, hairdressers, quaternary ammonium
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum punctionBiological
A blood sample inclusion and at the end of study visit
skin swab in elbow foldsBiological
passage of a cotton swab in the crease of the elbow at the inclusion
| Study group | Role | What they receive |
|---|---|---|
| First year students | Other | Students in their first year of Hairdressing School Receives: Biological: serum punction; Biological: skin swab in elbow folds |
| Third year students | Other | Students in their third year of Hairdressing School Receives: Biological: serum punction; Biological: skin swab in elbow folds |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between prevalence of quaternary ammonium sensitization between first and third year hairdressing students
Sensitization will be evaluated as the percentage of students with serum anti-Quaternary Ammonium IgE concentration >0,35 KU/L
Measured: 1 day
Secondary outcomes (4)
Comparison of quaternary ammonium sensitization of hairdresser to a age-matched birth cohort
The difference in prevalence of quaternary ammonium sensitization (seric IgE>0,35 kU/L) between the first year students and a reference population of the same age and geographic origin
Measured: 1 day
Evaluation of the link between quaternary ammonium sensitization and other measured biological parameters and clinical data collected
Measure of the correlation between all collected parameters and concentrations of anti-quaternary ammonium concentrations
Measured: 1 day
the relative variation of IgE anti-quaternary ammonium concentrations of first year students at inclusion and after two years of study
Measured: 2 years
the relative variation of IgG anti-quaternary ammonium concentrations of first year students at inclusion and after two years of study
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start27 Oct 2022
- Primary completion27 Oct 2022
- Study completion27 Oct 2022
Why it stopped: there is not enough volounteer for the trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quaternary AmmoniumStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luc de Chaisemartin, MD PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05247567
- Sponsor's protocol ID
- APHP211212
- Other IDs
- 2021-A01722-39
- Acronym
- AQTIFF
- Status last verified
- Mar 2024
- First submitted
- 9 Feb 2022
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quaternary Ammonium and Immunization in Hairdressers
- ClinicalTrials.gov ID
- NCT05247567
- Acronym / sponsor ID
- AQTIFF / APHP211212
- Conditions
- Quaternary Ammonium, Hypersensitivity
- Keywords
- hypersensitivity, hairdressers, quaternary ammonium
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: there is not enough volounteer for the trial
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 27 Oct 2022 (actual)
- Primary completion
- 27 Oct 2022 (actual)
- Study completion
- 27 Oct 2022 (actual)
- First posted
- 21 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
"Quaternary ammonium ions (QA) are surfactants and microbicide products found in a large number of household products, disinfectants and cosmetics.
Professional exposure to QA causes allergic diseases of the skin and lung (asthma). It is also the firs cause of occupational rhinitis since 2000.
Several studies have found a link between exposure to some disinfectants and asthma in specific population. Moreover, a study showed that exposure to QA found in hairdressing products could also be a risk factor to allergy to neuro-muscular blocking agents.
However, the prevalence of QA sensitization amongst hairdressers is not known, sensitization mechanisms have been poorly characterized. To date, there is no recommendation regarding QA exposure nor classification of QA by toxicity. Finally, the link between hairdressing QA and drug allergy have not been confirmed yet.
The investigator hypothesize that it is possible to sensitize to QA by exposure to hairdressing products and then to declare allergic diseases. The investigator plan to study this hypothesis in an observational prospective cohort of hairdressing students by measuring both sensitization markers in blood and QA exposure. "
Detailed description
Quaternary ammonium ions (QA) are surfactants and microbicide products found in a large number of household products, disinfectants and cosmetics.
Professional exposure to QA causes allergic diseases of the skin and lung (asthma). It is also the first cause of occupational rhinitis since 2000.
Several studies have found a link between exposure to some disinfectants and asthma in specific population. The responsibility of the QA in asthma can be demonstrated by in vivo testing (inhalation challenge). Some QA have been shown to directly activate the immune system, in particular didecyldimethylammonium chloride, a common disinfectant, that was demonstrated to act as a sensitizer.
Neuromuscular blocking agents (NMBA) are drugs used during surgery to relax muscles. They all have QA moieties and can trigger sometimes severe IgE-mediated allergic reaction (anaphylaxis). The epitope of these drugs recognized by the Immunoglobulin E (IgE) antibodies are precisely the QA moieties. However, the origin of these IgE is unknown as a significant proportion of patients have anaphylaxis on the first exposure an NMBA. A study showed that exposure to QA found in hairdressing products was linked to anti-IgE QA and then might also be a risk factor to allergy to NMBA.
Thus, QA exposure is strongly suspected to be linked to allergic diseases. However, the prevalence of QA sensitization amongst hairdressers is not known, sensitization mechanisms have been poorly characterized. To date, there is no recommendation regarding QA exposure nor classification of QA by toxicity. Finally, the link between hairdressing QA and drug allergy have not been confirmed yet.
We hypothesize that it is possible to sensitize to QA by exposure to hairdressing products and then to declare allergic diseases. We plan to study this hypothesis in an observational prospective cohort of hairdressing students by measuring both sensitization markers in blood and QA exposure.
The investigator will study 2 groups of hairdressing students :
- first year students, before the beginning of their apprenticeship in a Salon
- third year students Both groups will be programmed for a visit in the Center for Clinical Investigation of the Bichat Hospital, Paris, France. During this visit, after obtention of written consent, a blood sample (10 mL) will be collected in a serum collection tube, and a form about exposure to QA will be filled by the student.
For first year students only, a similar visit will be planned at the end of their studies (2 years after inclusion) Serum will be collected and frozen in a biobank in Bichat Hospital. Total and QA specific IgE and Immunoglobulin G (IgG) will be measured.
Differences in prevalence will be assessed by Fischer's exact test, the link between exposure levels and IgG and IgE levels will be assessed by Spearman correlation, and the evolution of IgE and IgG concentrations over time will be measured by a paired hypothesis test chosen according to data's distribution."
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First year students | Other | Biological: serum punction, Biological: skin swab in elbow foldsStudents in their first year of Hairdressing School |
| Third year students | Other | Biological: serum punction, Biological: skin swab in elbow foldsStudents in their third year of Hairdressing School |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Being at least 16
- Being regularly registered in a Hairdressing school in first and second year
- Mastery of French language
Key exclusion criteria (3 listed)
- No French speaking parents for underage students
- People under legal guardianship
- French special Health Insurance for non-residents (AME)"
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| serum punctionA blood sample inclusion and at the end of study visit | Biological | First year students, Third year students |
| skin swab in elbow foldspassage of a cotton swab in the crease of the elbow at the inclusion | Biological | First year students, Third year students |
Primary outcome
Difference between prevalence of quaternary ammonium sensitization between first and third year hairdressing students
Time frame: 1 day
Sensitization will be evaluated as the percentage of students with serum anti-Quaternary Ammonium IgE concentration >0,35 KU/L
4 secondary outcomes
Comparison of quaternary ammonium sensitization of hairdresser to a age-matched birth cohort
Time frame: 1 day
Evaluation of the link between quaternary ammonium sensitization and other measured biological parameters and clinical data collected
Time frame: 1 day
the relative variation of IgE anti-quaternary ammonium concentrations of first year students at inclusion and after two years of study
Time frame: 2 years
the relative variation of IgG anti-quaternary ammonium concentrations of first year students at inclusion and after two years of study
Time frame: 2 years
Results and safety
The study was stopped early (reason given: there is not enough volounteer for the trial). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luc de Chaisemartin, MD PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing serum punction and skin swab in elbow folds in people with Quaternary Ammonium and Hypersensitivity, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: there is not enough volounteer for the trial). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference between prevalence of quaternary ammonium sensitization between first and third year hairdressing students (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2024.